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Completed

NCT Number: NCT07522502

Metabolic and Immunoinflammatory Profiles in Adults With Newly Diagnosed Diabetes

The goal of this observational study is to better understand how diabetes develops in adults at the time of diagnosis. The study focuses on adults with newly diagnosed diabetes in the Kazakh population.

The main questions it aims to answer are:

* How do insulin resistance and beta-cell function differ between participants? * How is the immune system involved at the early stage of diabetes? * How are inflammation markers related to metabolic changes?

Participants undergo clinical and laboratory assessments at diagnosis. These include:

* Measurement of body mass index (BMI) and blood glucose control (HbA1c) * Assessment of insulin resistance and beta-cell function using HOMA2 indices * Measurement of C-peptide levels * Testing for islet autoantibodies (GADA, IA-2A, ZnT8A, ICA) * Measurement of inflammatory markers, including interleukin-1 beta (IL-1β) and interleukin-1 receptor antagonist (IL-1Ra) This study aims to improve understanding of different forms of adult-onset diabetes and support more personalized approaches to diagnosis and treatment.

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Key information

About this study

Adult-onset diabetes is increasingly recognized as a heterogeneous condition with diverse underlying pathophysiological mechanisms. At the time of diagnosis, individuals may present with varying degrees of insulin resistance, impaired beta-cell function, and immune activation. However, traditional classifications based mainly on glycemic parameters do not fully capture this complexity.

This study aims to provide an integrated assessment of metabolic and immunoinflammatory features in adults with newly diagnosed diabetes. Particular attention is given to the interplay between insulin resistance, beta-cell function, and immune-mediated processes, including islet autoimmunity and inflammatory signaling pathways.

The study focuses on key metabolic indicators such as body mass index, glycemic control, C-peptide levels, and indices derived from the HOMA2 model, as well as immunological markers including islet autoantibodies and cytokines involved in the interleukin-1 pathway. The balance between pro-inflammatory and anti-inflammatory activity is assessed through the IL-1β/IL-1Ra ratio.

By integrating metabolic and immunological data, this study seeks to better characterize early-stage heterogeneity of adult-onset diabetes and to contribute to improved phenotypic classification. A more comprehensive understanding of these mechanisms may support the development of more personalized approaches to diagnosis and disease management in diverse populations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 25 years and older
  • Kazakh population with newly diagnosed diabetes mellitus
  • Diagnosis established in routine clinical practice
  • No prior insulin therapy at the time of enrollment
  • No prior use of glucose-lowering therapy beyond initial management
  • Ability and willingness to provide informed consent

Exclusion criteria

  • Clinical features suggestive of classical type 1 diabetes at presentation
  • History of long-term insulin therapy prior to enrollment
  • Severe acute illness or infection at the time of assessment
  • Pregnancy
  • Incomplete clinical or laboratory data

Treatment and study plan

Primary outcomes

  1. IL-1β / IL-1Ra Ratio

    Time frame: Baseline

    Assessment of the serum IL-1β/IL-1Ra ratio as a marker of immunoinflammatory balance in adults with newly diagnosed diabetes, with comparison according to islet autoantibody status.

Secondary outcomes

  1. Serum IL-1Ra Level

    Time frame: Baseline

    Measurement of serum interleukin-1 receptor antagonist (IL-1Ra) levels in adults with newly diagnosed diabetes according to islet autoantibody status.

  2. Serum IL-1β Level

    Time frame: Baseline

    Measurement of serum interleukin-1 beta (IL-1β) levels in adults with newly diagnosed diabetes according to islet autoantibody status.

  3. Basal C-Peptide Level

    Time frame: Baseline

    Assessment of basal C-peptide concentration as a marker of beta-cell function in adults with newly diagnosed diabetes.

  4. HOMA2-IR

    Time frame: Baseline

    Assessment of insulin resistance using the HOMA2-IR index in adults with newly diagnosed diabetes.

    HOMA2-IR calculated from fasting glucose and fasting insulin at diagnosis. No fixed minimum or maximum score; higher scores indicate worse insulin resistance. In published population-based studies of adults, thresholds for insulin resistance typically range from approximately 1.8 to 2.0.

  5. HOMA2-%B

    Time frame: Baseline

    Assessment of beta-cell function using the HOMA2-%B index in adults with newly diagnosed diabetes.

  6. HbA1c

    Time frame: Baseline

    Assessment of glycemic control using glycated hemoglobin levels in adults with newly diagnosed diabetes.

  7. Islet Autoantibody Status

    Time frame: Baseline

    Determination of islet autoantibody positivity based on GADA, IA-2A, ZnT8A, and ICA testing in adults with newly diagnosed diabetes.

  8. Fasting Plasma Glucose

    Time frame: Baseline

    Measurement of fasting plasma glucose levels in adults with newly diagnosed diabetes.

  9. Fasting Insulin Level

    Time frame: Baseline

    Measurement of fasting insulin levels as part of metabolic assessment in adults with newly diagnosed diabetes.

  10. Glutamic Acid Decarboxylase Antibody (GADA) Positivity

    Time frame: Baseline

    Determination of glutamic acid decarboxylase antibody (GADA) positivity in adults with newly diagnosed diabetes.

  11. Islet Antigen-2 Antibody (IA-2A) Positivity

    Time frame: Baseline

    Determination of islet antigen-2 antibody (IA-2A) positivity in adults with newly diagnosed diabetes.

  12. Zinc Transporter 8 Antibody (ZnT8A)

    Time frame: Baseline

    Determination of zinc transporter 8 antibody (ZnT8A) positivity in adults with newly diagnosed diabetes.

  13. Islet Cell Antibody (ICA)

    Time frame: Baseline

    Determination of islet cell antibody (ICA) positivity in adults with newly diagnosed diabetes.

Sponsors and collaborators

Lead sponsor

West Kazakhstan Marat Ospanov Medical University

Other

Collaborators

  • Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Registry information

Official study title

Clinical, Metabolic, and Immunoinflammatory Characteristics of Adult-Onset Diabetes at Diagnosis: A Cross-Sectional Study in the Kazakh Population

Acronym: AD-HET-KZ

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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